Regulatory medical writing in clinical trials requires medical writers to possess sufficient knowledge of the regulatory guidelines of concerned authorities of specific countries and needs to have dedication and commitment to handle large volumes of regulatory data. A professional regulatory writer needs to have sufficient understanding of the drug development process to determine the important documents that need to be written and submitted for regulatory submissions.
Regulatory submissions challenges in clinical trials
Regulatory Writing and Publishing poses many challenges for the medical writers in the writing and development of critical documents like Clinical Study Report, Investigator’s Brochure, and clinical trial protocol development and in the preparation of documents for FDA meetings and briefings.
The Clinical Study Report (CSR) is a critical document that provides an integrated report comprising the clinical and statistical description of the investigational study of therapeutic or prophylactic drugs in a single report with relevant tables, figures, and appendices. A medical writer will face challenges in understanding the guidelines and statutory requirements and also developing suitable document template that covers all current regulatory requirements.
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